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The aim of this article is to provide some guidance to fresh graduates, nurses, pharmacists, laboratory staff and those working in allied fields both in the pharmaceutical industry and NHS who wish to begin a career in clinical research.
Two Starting Points
The industry can be divided into two halves: the pharmaceutical companies, who develop medical products and the clinical research organisations (CROs) who provide a range of services including resources and expertise to pharmaceutical companies. If you are just starting on your career path then you may find it easier to enter the industry via a CRO. I have worked for both CROs and pharmaceutical companies and believe that both have a lot to offer. I would say that my experiences in both CROs and pharmaceutical companies have added together to broaden the scope and depth of my knowledge of clinical research.
The Clinical Research Associate
Whilst there are many functions and roles within clinical research the one that most people seem to know about, and the one I will focus on in this article, is Clinical Research Associate (CRA). Whilst CRA is perhaps the most widely used job title to describe the role of the clinical monitor other titles are sometimes used such as Clinical Research Scientist or Clinical Trial Monitor.
Most people will associate the CRA with study monitoring. However, the activities of most CRAs extend way beyond verifying and checking data at the investigator's site (Hospital or GP Surgery). CRAs with experience in a therapeutic area may be asked to provide input into the protocol, the document that describes the design, methodology and organisation of the trial. They will often review and provide input into the development of essential study documents such as the consent form or clinical research agreements. CRAs are responsible for selecting investigators and may assist investigators to obtain approval from ethics committees. They may be asked to give a presentation at an investigator or monitors' meeting. Before the study starts, the CRA will ensure that the investigator and other site staff, such as study nurses and pharmacists, understand all their responsibilities and, if necessary, are provided with training. This training may be focused on the protocol, or can be designed for site staff with little or no knowledge of clinical research, to give a thorough grounding in Good Clinical Practice (GCP). Once the study has started, the site will be visited regularly to ensure that the data collected are complete and accurate. The period between visits will vary depending on the number of patients, complexity of the study and the experience of site staff.
Data collected during the clinical trial are entered into Case Report Forms (CRFs). CRAs will verify these data against entries in the original documents (source documents) such as patients' notes and laboratory reports, in a process known as source document verification (SDV).
One important document that all CRAs will look at closely is the informed consent form (ICF). Patients are asked to read the information in the ICF and then sign and date the form which confirms that the patient was given all the relevant information about the clinical trial, and that they understood that they are participating voluntarily in the study, without obligation. The CRA will check that the patients have personally signed and dated this form and that the correct version of the form was given to the patients in cases where there have been amendments or updates.
The CRA will check that all adverse events that occur during the study are reported and followed up. Clinical supplies are checked and drug accountability will be performed. During the study a CRA will be asked many questions and be faced with many issues. One thing that they can expect is the unexpected and they will need to ensure that any questions or issues they are faced with have been adequately answered or dealt with.
What are the skills of a CRA?
CRAs have to be good communicators. You may be working with hospital specialists such as surgeons, cardiologists and oncologists or you may be involved with GPs. You will also be dealing with nurses, scientists, pharmacists and administrative staff. How you interact with these personnel is just as important as attention to detail and all the other skills of a CRA. The successful CRA is confident, professional and a good communicator. You will need good influencing and negotiating skills and be able to demonstrate that you are reliable by following up on issues and queries from the site. Your company will perceive you as someone who not only performs their monitoring duties but also someone who is able to contribute to the study team. You will be expected to be self-motivated and capable of working alone. Indeed, many monitors work from home (field-based CRAs). Quite often this is very attractive to monitors who have a degree of flexibility and independence. There are often periods of hectic activity followed by times when there is less to do. The organised and self-disciplined monitor can perform all their duties and have a little extra free time. On the other hand if you let things slip or take on too much work then you may find yourself working evenings or weekends.
As technology advances, more and more CRAs are becoming involved in electronic data capture which involves recording data in electronic CRFs. CRAs may have to provide training and support to investigators who are not familiar with such systems. Monitors may have to use systems at the site, which hold electronic patient records. They may have to perform online subject tracking or become involved in internet-based training or conferencing. As the pharmaceutical industry adopt new technologies, CRAs will need to acquire new skills to use, train and support these new applications and systems.
How to get started.
If you are considering becoming a CRA and have little or no experience then you may now be wondering what steps you can take to increase your chances of getting a CRA position. Many find that getting your foot in the door is not always easy. Companies often need people quickly and may not have the time to train you. So how do you get that first CRA job?
The experienced CRA must have started somewhere. In my case, I was lucky enough to know a CRA who was willing to spend the time to explain the job in detail. In addition, I read a great deal about drug development and the guidelines for Good Clinical Practice (1). I worked in a teaching hospital and so was able to see the tasks and activities that the CRA carried out. During my interview for a CRA position, I was asked detailed questions and given scenarios where I had to make decisions. Fortunately, the research that I had done was enough to get me my first monitoring assignment.
Reading Material
There are a number of books that you will find useful, giving you a basic understanding of running clinical trials. For a concise introduction to the pharmaceutical industry and running clinical trials I would recommend "Consider It Pure Joy" (2) (costing around £10). This book contains a section on clinical research associates including what they do and what challenges they experience. For a more in-depth look at the industry and clinical trials I would suggest "Principles of Clinical Trials" (3) (cost around £50) available through the Institute of Clinical Research. This takes you through the discovery of potential new medicines, the stages of clinical development and post registration studies. Ethical issues, health economics and statistical thinking are also covered. There is a section on communicating effectively, which covers writing clinical study reports and publications as well as speaking at meetings. There are various documents such as the ICH guideline (topic E6)(1) which covers Good Clinical Practice. If you are new to the industry I would strongly recommend that you read this before attending any interview. The reading list below suggests a further ICH Guideline that covers the running of clinical trials (4).
The Institute of Clinical Research has a website (www.instituteofclinicalresearch.org ) with useful information and details on how to become a member. Members receive copies of the Institute's journal called Clinical Research Focus. This journal is published 8 times a year and keeps its members up to date with articles on best practice and career development as well as advertising current CRA positions. Members also receive a membership book which lists all current members and gives contact details for all pharmaceutical companies and CROs in the UK.
What training is available?
The MSc in Clinical Research run by John Moores University in conjunction with the Institute of Clinical Research is a useful qualification. Alternatively you could attend one of the short courses run by the Institute of Clinical Research such as clinical trial practice and monitoring. ETAD is currently running a training programme. Delegates are not only trained as a CRA but have a much greater chance of finding a position after the 7 day programme. For further information about current courses, visit the website http://www.etad-ltd.com and go to courses 2002.
Your approach to finding a CRA position
Once you have done all your homework you will need to apply for positions. It pays to organise and manage your time effectively (see Bob Gammons article on time management 06/10/2001). Make sure you prioritise. Make the calls you need to during the day. Keep a tidy and up to date file of all your contacts, communications and conversations. If someone offers to help or send on your details make sure you acknowledge this. Make your CV shine for you. It may be the first point of contact with your future employer. Make sure you have researched the company and its products or services.
Finally, as I indicated at the beginning of this article, there are many functions and roles within clinical development. This article has dealt with just one, that of the Clinical Research Associate. Nevertheless, the advice given holds good for other roles which will be described in future articles. I have found clinical research to be an interesting and rewarding career. I hope you will find this true for you.
Further reading
- ICH guideline (1996) Topic E6 Good Clinical practice - Consolidated guideline, International Federation of Pharmaceutical Manufacturers Associations. Geneva. (issued as CPMP/ICH/291/96).
- Raven A (1997) Consider it a pure joy. An Introduction to Clinical Trials. (3rd edn) Cambridge Healthcare Research, Cambridge.
- Ignazio Di Giovanna and Gareth Hayes (2001) Principles of clinical research. Wrightson Biomedical publishing Ltd.
- ICH guideline (1997) Topic E8 General considerations for clinical trials International Federation of Pharmaceutical Manufacturers Associations. Geneva. (issued as CPMP/ICH/363/96).
Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use.
Official Journal L 121 , 01/05/2001 P. 0034 - 0044 available online at: http://europe.eu.int/eur-lex/en/index.html
Guidance documents available online at: http://pharmacos.eudra.org/F2/pharmacos/docs.htm#news
Copyright © 2009 PDR Partners, incorporating Bob Gammon Associates. |
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